Regulatory

Found 23,263 articles

• US FDA Warns VaxGen Over Anthrax Vaccine Promotion

  4/4/2006

• AVANIR Pharmaceuticals's Neurodex NDA Accepted With Priority Review For Involuntary Emotional Expression Disorder

  4/4/2006

• Serono International S.A. Submits New Formulation Of Rebif(R) For Approval In The United States And In Europe

  4/4/2006

• Edison Pharmaceuticals, Inc. Announces FDA Grants EPI-A0001 Orphan Drug Designation For Inherited Mitochondrial Respiratory Chain Diseases

  4/4/2006

• Andrx Corporation Announces Filing Of NDA By Takeda For ACTOS And Extended-Release Metformin Combination Product

  4/4/2006

• GlaxoSmithKline Receives Positive Data And Halts Enrollment In Phase III Trial Of Tykerb(R) (Lapatinib) In Advanced Breast Cancer

  4/3/2006

• Inhibitex, Inc. Reports Top-Line Results In Phase III Study Of Veronate(R) - Failed To Meet Its Primary Endpoint

  4/3/2006

• Ortho-Clinical Diagnostics Issues A Voluntary Product Recall For VITROS(R) Immunodiagnostic Products Signal Reagent

  4/3/2006

• Takeda Pharmaceutical Co. Ltd. Submits New Drug Application For Extended-Release Type 2 Diabetes Medication, ACTOplus Met(TM) (Pioglitazone HCl And Metformin HCl)

  4/3/2006

• Bioniche Life Sciences Inc. Receives FDA Approval To Proceed With Phase III Bladder Cancer Trials

  4/3/2006

• CancerVax Corporation Announces FDA Approval Of IND For Novel Anti-Angiogenic Antibody D93

  4/3/2006

• Akorn-Strides, LLC Announces First ANDA Submission

  4/3/2006

• SpectraScience, Inc. Receives Facility Approval From The FDA

  4/3/2006

• Boston Scientific Corporation Receives FDA Clearance For Super Sheath(TM) Introducer Sheath

  4/3/2006

• Gen-Probe Incorporated Submits Amended Regulatory Application For PROCLEIX(R) ULTRIO(R) Assay To FDA

  3/30/2006

• Cardiome Pharma Corp. - New Drug Application Submitted For RSD1235

  3/30/2006

• MDS Inc. Provides Update On Review Of Montreal Bioanalytical Operations

  3/30/2006

• Biogen Idec, Inc. (Massachusetts) And Elan Corporation PLC Announce Re-Initiation Of TYSABRI(R) Clinical Trial Dosing In Multiple Sclerosis

  3/29/2006

• Genentech, Inc. And Biogen Idec, Inc. (Massachusetts) Submit Supplemental Biologics License Application For First-Line Use Of Rituxan(R) In Low-Grade Or Follicular CD20-Positive B-Cell Non-Hodgkin's Lymphoma

  3/29/2006

• NPS Pharmaceuticals, Inc. Updates Status Of PREOS(R) NDA

  3/29/2006